Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This phase Ib/II trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, to shrink the tumor before the main treatment is given (neoadjuvant), followed by surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). In cases where patients are not candidates for the standard of care approach or prefer a bladder sparing option, tri-modality therapy with transurethral resection of bladder tumor (TURBT) followed by combined chemotherapy and radiation therapy is used. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Giving enfortumab vedotin with pembrolizumab and radiation therapy may work better in treating patients with muscle invasive bladder cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony biopsją rak pęcherza moczowego z naciekiem na mięśnie.
- •Pacjent nie może lub nie chce poddać się standardowej operacji usunięcia pęcherza.
- •Pacjent może przyjąć radioterapię na pęcherz.
- •Pacjent musi mieć wykonaną biopsję lub usunięcie części guza pęcherza nie wcześniej niż 8 tygodni przed rozpoczęciem leczenia.
- •Pacjent ma ukończone 18 lat.
- •Ogólny stan zdrowia pacjenta pozwala na udział w badaniu (ocena wg skali ECOG).
✗ Disqualifies
- •W badaniu nie mogą wziąć udziału pacjenci z pewnymi typami nowotworów pęcherza, np. z drobnokomórkowym rakiem pęcherza.
- •Pacjenci z chorobami autoimmunologicznymi, którzy są aktywnie leczeni lekami immunosupresyjnymi (np. sterydami w dawce powyżej 10 mg prednizonu dziennie).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 1, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
University of California, San Francisco
San Francisco, United States
Trial contact
UCSF Genitourinary Medical Oncology Recruitment
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/2/2026.
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